FDA delays PDUFA for Keryx's Zerenex

Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) said FDA delayed by three months the PDUFA date for Zerenex ferric citrate to treat hyperphosphatemia in dialysis-dependent patients with chronic kidney disease (CKD). The new PDUFA date is Sept. 7; it was June 7. Keryx said FDA needs additional time to review CMC information submitted by the company per an FDA request.

An MAA for Zerenex to treat hyperphosphatemia in dialysis-dependent and non-dialysis-dependent CKD patients is also under EMA review. In January, Japan approved the oral ferric iron-based phosphate binder as Riona. Keryx has worldwide rights to the product, including Japan but excluding the rest of the Asia Pacific region, from Panion & BF Biotech Inc. (Taipei, Taiwan). ...